Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Covidien IIc, FA1355, Palindrome Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8 mm) x 23 cm

   Bij analyse na het in de handel brengen werd vastgesteld dat bij sommige kathetersets in vier (4) specifieke loten van de ...

   Waarschuwing | 28-08-2023

2. Invivoscribe, Inc., 3014173060-07-18-23-003-C, LymphoTrackDx IGH - MiSeq

   The impacted master mix lots, when used to amplify clinical samples, will not produce amplification of the VH7 region. In the ...

   Waarschuwing | 28-08-2023

3. Siemens Healthcare Diagnostics Inc., CHC 23-02, ADVIA Chemistry Iron_2 (IRON_2) Reagents

   Siemens Healthcare Diagnostics Inc. has confirmed, through investigation of customer complaints, the potential for a positive ...

   Waarschuwing | 28-08-2023

4. B.Braun Melsungen AG, FSCA-2023-08-14(1), INFUSOMAT SPACE

   Tijdens de Post Market Surveillance-activiteiten hebben we een sporadisch voorkomen van mogelijk valse down- en upstream ...

   Waarschuwing | 28-08-2023

5. Medima Sp. z o. o., FSCA-2023-01, Volumetric infusion pump & infusion sets

   Issue 1: Potential for reverse installation of infusion sets intoMedima Volumetric infusion pumps. Issue 2: Potential for a ...

   Waarschuwing | 24-08-2023

6. Acutronic Medical Systems AG, FSCA-23-003, Acutronic Medical Systems AG TV1 Ventilator

   The device life of 5 years has been reached and/or exceeded for the TV1 Ventilators. As Acutronic will no longer be supporting ...

   Waarschuwing | 24-08-2023

7. Medline International France SAS, FSCA-23/07 / FSCA-23-07, Magnetic Instrument Drape MDL1CE

   Medline brengt deze terugroeping uit om klanten te informeren over de mogelijkheid van een zwakke verzegeling die de steriele ...

   Waarschuwing | 24-08-2023

8. Bard Peripheral Vascular, Inc., PI-23-4795, Bard Marquee Disposable Core Biopsy Instrument Kit

   Op basis van feedback van klanten heeft BD vastgesteld dat de diameter van de coaxiale canule en de biopsienaald (snijcanule) in ...

   Waarschuwing | 22-08-2023

9. Premier Guard Zhongshan Limited, 3503, Quest Spectrum Drape for Open Surgery PG

   Quest has initiated this FSCA removal action after receiving a complaint regarding the plastic cover glass of the drape that ...

   Waarschuwing | 21-08-2023

10. AB SCIEX Pte. Ltd., FSCA-2023-177083, 4500MD and Citrine LC-MS/MS Systems

    In rare occasions, the combination of a leak of a highly flammable solvent at the ion source pro be, and an electrical discharge ...

    Waarschuwing | 21-08-2023